Kornimate/medical-research-clean huggingface dataset:
immune activation markers in hiv-infected patients switching to long acting dual therapy

Conditions: HIV-1-infection

Summary: the purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cart) to a long acting dual therapy in hiv-infected patients

patients meeting the inclusion criteria will be offered to participate to the study. in case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up. six months after cart change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers

Eligibility criteria:
inclusion criteria: * patients agreeing to participate to the study and to collect their data * hiv-1 infected subjects * patients switching from a stable (at least 6 months) and successful triple cart to a long acting dual cart * patients older than 18 yrs and regularly followed in cannes and nice hospitals * patients with a healthcare card exclusion criteria: * hiv-2 infected subjects * patients not being on successful and stable cart * patients having being treated during acute hiv-infection * patients modifying cart for virological failure * subjects modifying their treatment for another combination than from a triple cart to a dual cart * patients modifying cart during the 6 months of follow-up * patients refusing to participate to the study * patients included in an interventional study during the 6 months of follwo-up * patient under juridical procedure

Keywords: inflammatory markers dual therapy treatment simplification
ionizing radiation during endoscopic procedures (endoray study)

Conditions: Gastro-Intestinal Disorder

Summary: the primary objective of this prospective study was to describe the evolution of dose reference levels (drls) in a specialized french center during endoscopic procedures involving ionizing radiation and performed without a radiology technician. the secondary objective was to assess the influence of the operator on the recorded dose for each procedure.

this prospective study, approved by the institutional review board (irb) of the groupement de coopération sanitaire ramsay santé (approval no. 2019-06-010), was conducted in the endoscopy unit of jean mermoz hospital (lyon, france). to standardize practices, all operators underwent blended training (3 hours of e-learning and 3 hours of hands-on training on the shine enhancer system), which was completed and validated on june 25, 2018. as per guidelines, the graphic (cine) mode was never used. only the latest fluoroscopic images were printed and archived. the database includes all consecutive patients who underwent an endoscopic procedure between june 26, 2018, and december 31, 2021. each report was retrospectively reviewed to confirm the therapeutic intention (intention-to-treat). initially, only the type of procedure and the dose-area product (dap) were recorded. from october 7, 2019, fluoroscopy time (ft) was also systematically collected. six experienced endoscopists performed all procedures. the patient's position varied depending on the procedure, although most were performed in the supine position under general anesthesia. no radiologic technician was present during the procedures. the fluoroscopic system was entirely managed by the endoscopist, including all parameter adjustments (distance between patient and detector, use of pulsed vs continuous fluoroscopy, collimation, duration, etc.). two mobile c-arm x-ray systems were used throughout the study: siemens arcadis and ge oec fluorostar, both under-couch systems.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older, who have been informed of the research; * patients who have undergone an endoscopic procedure under radiological control * subjects for whom all data concerning the methods of exposure to ionizing radiation are available; exclusion criteria: * patient under legal protection, guardianship, or curatorship; * patient who has indicated their opposition to the use of their medical data (by completing and returning the opposition form that will be sent to them).
s-11 smr tt hybrid glenoid and cementless finned short stem

Conditions: Shoulder Arthritis; Shoulder Osteoarthritis; Arthrosis; Osteoarthritis; Rheumatoid Arthritis; Arthroplasty; Avascular Necrosis; Humeral Fractures; Cuff Tear Arthropathy

Summary: post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with smr tt hybrid glenoid with or without smr cementless finned short stem


Eligibility criteria:
inclusion criteria:(key) * both genders; * age ≥ 18 years old; * full skeletal maturity; * life expectancy over 5 years; * patient is requiring primary unilateral arthroplasty based on physical examination and medical history; * good bone quality evaluated by the investigator and the intraoperative evaluation; * a diagnosis in the target shoulder of one or more of the s-11 smr tt hybrid glenoid and cementless finned short stem version sep 2021 2.0 confidential page11 following: 1. primary osteoarthritis; 2. secondary osteoarthritis; 3. post-traumatic arthritis; 4. rheumatoid arthritis; 5. avascular necrosis 6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods; 7. cuff tear arthropathy (only in combination with cta heads); 8. glenoid arthrosis without excessive glenoid bone loss: a1, a2 and b1 according to walch classification. exclusion criteria (key): * patient requiring revision shoulder arthroplasty; * osteoporosis with a history of non-traumatic fractures; * steroid injections within the previous 3 months; * contralateral shoulder replacement within the previous 3 months; * significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the investigator; * significant neurological or musculoskeletal disorders that may compromise functional recovery; * not recovered axillary nerve palsy; * non functioning deltoid muscle; * known or suspicious hypersensitivity to the metal or other components and materials of the implant; * participation in any experimental drug/device study within the 6 months prior to the preoperative visit; * women of childbearing potential who are pregnant, nursing, or planning to become pregnant. these are key eligibility criteria, other eligibility criteria apply.

Keywords: shoulder joint shoulder replacement arthritis with rotator cuff tear post traumatic fracture sequele
the supplementary effects of the extract of agaricus blazei murril on type ii diabetes mellitus (dm)

Conditions: Diabetes Mellitus, Type II

Summary: the purpose of this study is to examine whether the extract of the agaricus blazei murill mushroom is effective in the supplementary treatment of type ii dm patients.

the researchers have the animal model that the extract of the agaricus blazei murill mushroom is effective in the treatment of type ii dm mice conducted on 2002. the dose effects were also found. the researchers conducted the pilot study also showing the same effects in 2003. so the researchers designed this trial. the elixir of the agaricus blazei murill mushroom is popular in taiwan for chronic diseases, such as type ii dm.

Eligibility criteria:
inclusion criteria: * type ii dm * age 20-75 years old * treat with gliclazide and metformin * signed informed consent exclusion criteria: * got/gpt \>80/80 * creatinine \> 2.0 * lactating or pregnant women

Keywords: agaricus blazei murill type ii dm insulin index
pharmacokinetics and pharmacodynamics of mtr105 in hypotensive cardiac surgery patients

Conditions: Hypotension; Cardiopulmonary Bypass

Summary: the purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of mtr105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

the study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of mtr105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.

Eligibility criteria:
inclusion criteria: * men or women age 18 years or older * referred for cardiac surgery requiring the use of cpb. * elective or urgent surgeries (non emergency operations). * lvef ≥40 based on cardiac catheterization results * normal renal function at study entry * normal hepatic function (within normal laboratory ranges) at study entry * normal coagulation status at study entry as judged by pt, ptt, fibrinogen and platelet count. * willingness to participate in the study and adhere to the study design. * willingness to sign an informed consent form. exclusion criteria: * emergency operation * pulmonary hypertension (pa systolic pressure \>60 mmhg) * ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8 * neurological events such as prior cva, tia or symptomatic carotid stenosis within 1 year of presenting for surgery * body weight \<40 kg * pregnancy * malignancy within 1 year of presenting for surgery * systemic infection as evidenced by elevated wbc or fever \>38.5 c * usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction. * participation in any other investigational drug or device study within 30 days of randomization
association of t1-mapping and lv strain analysis by cmr

Conditions: Myocardial Fibrosis

Summary: the association of t1-mapping (both native and ecv) and strain analysis of lv and rv by cmr will be assessed. results from strain analysis will be investigated in terms of their prognostic value.


Eligibility criteria:
inclusion criteria: * undergoing cmr * willingness to participate exclusion criteria: * \<18 years old * pregnancy
autonomic neural regulation therapy to enhance myocardial function in heart failure (anthem-hf) study

Conditions: Congestive Heart Failure

Summary: the anthem-hf study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (vns) with the cyberonics vns therapy system for the treatment of subjects with symptomatic heart failure.

heart failure patients will be enrolled and randomized to cervical vns implantation on either the left side or right side. after a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 6 months, with data collection at 3 months and 6 months.

Eligibility criteria:
inclusion criteria: * patients with symptomatic heart failure, new york heart association (nyha) class ii/iii with reduced ef and dilated hearts

Keywords: heart failure vagus nerve vns
mobilization of stem cells with plerixafor, chemotherapy and g-csf in multiple myeloma or non-hodgkin's lymphoma patients

Conditions: Lymphoma, Non-Hodgkin; Multiple Myeloma

Summary: patients with multiple myeloma (mm) and non-hodgkin's lymphoma (nhl) will be mobilized with chemotherapy and g-csf plus plerixafor (amd3100). the purpose of this protocol is to determine if plerixafor given after chemotherapy and g-csf mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (pbscs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (pmns) and platelets (plts).

an open label, multi-center, phase 2 study was conducted in patients with mm or nhl who were to be treated with peripheral blood stem cells (pbsc) autologous transplantation. the only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and g-csf. patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and g-csf (at customary doses) and apheresis was performed. after the first apheresis, plerixafor was given at 10pm, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. the change in the patient's peripheral cd34+ cell count between the plerixafor dose and the start of apheresis was measured. the apheresis yields on day 1 and day 2 were compared. this study was previously posted by anormed, inc. in november 2006, anormed, inc. was acquired by genzyme corporation. genzyme corporation is the sponsor of the trial.

Eligibility criteria:
inclusion criteria (abbreviated list): * mm in first partial response/complete response, first relapse, or second partial/complete response * nhl in first or second partial or complete remission * nhl patients who do not have bone marrow involvement and \< 10% for follicular involvement * mm patients who have stable disease with \< 40% bone marrow involvement * no more than three prior regimens of chemotherapy (thalidomide and decadron are not considered chemotherapy) * eastern cooperative oncology group (ecog) performance status of 0 or 1 * white blood cell count (wbc) \>3.0 x 10\^9/l * absolute neutrophil count \>1.5 x 10\^9/l * platelet count \>100 x 10\^9/l exclusion criteria (abbreviated list): * brain metastases or carcinomatous meningitis * hypercalcaemia \[\>1 mg/dl above the upper limit of normal (uln)\] * cardiovascular disease that includes proven or predisposition to ventricular arrhythmias * acute infection

Keywords: non-hodgkin's lymphoma multiple myeloma stem cell mobilization
evaluations of alcohol warning labels

Conditions: Oral Cancer; Esophageal Cancer; Larynx Cancer; Alcohol Drinking

Summary: the goal of this study is to determine the effectiveness of pictorial warning labels (pwls) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. participants will be randomized to view either three narrative or non-narrative pwls. key outcome variables include visual attention, message reactance, risk perceptions, and intentions to reduce and stop drinking.

the goal of this study is to determine the effectiveness of pictorial warning labels (pwls) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. participants will be recruited from online panels. participants will first be invited to participate in an online screening survey. eligible participants will be invited to participate in the main experiment. in the main experiment, participants will first answer questions concerning baseline alcohol consumption and other background information. then they will engage with a webcam-based eye-tracking task through sticky by tobii. participants will first read instructions and tips related to completing the eye-tracking task. they will complete a brief calibration procedure and be presented with either three narrative pwls or three non-narrative pwls. sticky by tobii will record participants' gaze, thereby measuring visual attention to each pwl. after viewing each pwl, participants will answer a few questions. after viewing all three pwls, they will answer questions based on all images combined. upon study completion, participants will be compensated. a follow-up survey will be sent to participants after two weeks, which includes questions about their drinking behaviors, information seeking behaviors, and social interactions.

Eligibility criteria:
inclusion criteria: 1. be at least 21 years old; 2. have consumed more than three alcoholic drinks per week over the past year; 3. be willing to participate in remote eye tracking tasks and have necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed internet and a computer/tablet/phone equipped with a high-speed camera). exclusion criteria: 1. be younger than 21 years old; 2. has not consumed more than three alcoholic drinks per week over the past year; 3. be not willing to participate in remote eye tracking tasks and have no necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed internet and a computer/tablet/phone equipped with a high-speed camera).
the impact of text messaging on medication adherence and exercise regimen among post-myocardial infarction patients

Conditions: Myocardial Infarction

Summary: the purpose of this study is to assess the impact of text message reminders on adherence to medications and exercise in patients recently discharged from the hospital after a myocardial infarction (mi).

the impact of text messaging on medication adherence and exercise regimen among post-myocardial infarction patients includes two single-center randomized control trials to assess the impact of text message reminds on adherence to medications and exercise regimen in patients recently discharged from the hospital after mi. recruitment conducted at cambridge cardiac rehabilitation in ontario, canada for both the medication adherence and exercise trial. potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either intervention or usual care (control). patients randomized to the intervention arm in the medication adherence trial receive an automated text message once per day at the time they are prescribed to take their medication. the text message does not contain any personal or pharmacological information. patients randomized to the intervention arm in the exercise adherence trial receive four text messages per day at 7:30 am, 12:00 pm, 6:00 pm, and 9:00 pm, reminding them to exercise for 30 minutes per day as per their health care provider.

Eligibility criteria:
inclusion criteria: * post-mi hospital discharge within 2 weeks * enrolled in cardiac rehabilitation * prescribed anti-platelets, beta-blockers, ace-inhibitors or arbs, and/or statins on 1x/day regimen (for medication adherence trial) * prescribed exercise regimen (for exercise trial) * ability to read and write english * possession of a cell phone with text messaging capability exclusion criteria: * age \< 18 * incarcerated individuals * unable to read and write english * not in possession of a cell phone * patients prescribed medication regimen \> 1x/day

Keywords: exercise adherence medication adherence mobile health cardiac rehabilitation
roflumilast in-vitro basophil release

Conditions: Allergy; Asthma

Summary: this study is looking for allergic asthmatics. lung and allergy testing will be done to verify. if qualified, blood will be drawn for laboratory studies.

non-smoking allergic asthmatics will be verified using pulmonary function, skin prick testing, exhaled nitric oxide and serum ige. if qualified, blood will be drawn, treated with study medication and then stimulated with the allergen to which the subject is allergic. mediators including histamine, il-13, il-4, and leukotrienes will be measured.

Eligibility criteria:
inclusion criteria: * age 19 and above allergic asthma serum ige greater than 30iu/ml exhaled nitric oxide greater than 17ppb exclusion criteria: * smoking history

Keywords: interleukin 13 interleukin 4 leukotrienes basophil histamine release
intranasal neurostimulation for the treatment of neurosensory abnormalities in cl wearers (intac)

Conditions: Contact Allergy; Neuropathic Pain

Summary: to find out if the use of an intranasal tear neurostimulator (itn), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.


Eligibility criteria:
inclusion criteria: * at least 21 years of age at screening visit * ocular surface disease index (osdi) score of less than 12 (without contact lens wear) * contact lens dry eye questionnaire (cldeq)-8 score of greater than 12.18 * regular contact lens wearer who wears them less than 6 hours per day due to discomfort * the presence of at least one microneuroma on in vivo confocal microscopy * self-reported good compliance with healthy contact lens regimen (replace contact lenses per manufacturer's recommendations, use of multipurpose or hydrogen peroxide contact lens solution nightly) * have had an eye exam within the last two years that included dispense of a contact lens prescription * proparacaine drops relieve at least 75% of ocular symptoms to ensure that patients do not have centralized neuropathic corneal pain * if a soft lens wearer, use a contact lens that was released within the last 15 years exclusion criteria: * use of topical drops other than artificial tear substitutes * ocular surgery or other ocular disease within 3 months prior to study enrollment * concurrent ocular disease that may impact results * have dry eye (as defined by 2 or more of the parameters below) * schirmer's wetting test \< 10mm * tbut \<7sec * nei scale corneal staining of 4 out of 15 at the time of enrollment * improper cl fit * no microneuroma by in vivo confocal microscopy * overnight wear within 1 month of screening visit * use of colored or cosmetic lenses * contra-indication to itn * chronic or recurrent epistaxis, coagulation disorders. * nasal or sinus surgery or significant trauma to the nose. * cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck. * chronic or recurrent nosebleeds * bleeding disorder * known hypersensitivity (allergy) to the hydrogel material * disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device. * history of migraines * under 21 years of age

Keywords: contact lens discomfort
assessment of health-related quality of life after switching copd patients from a dry powder inhaler to a soft mist inhaler remaining on the same inhalative drug

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this non-interventional, observational study is to assess whether changing chronic obstructive pulmonary disease (copd) patients from a dry powder inhaler (handihaler®) to a soft mist inhaler (respimat®), without changing the pharmacological compound, will lead to an improvement in clinical copd questionnaire (ccq) score and in the scores of the three subdomains of ccq score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks.


Eligibility criteria:
inclusion criteria: * participants ≥ 40 years of age at baseline visit * patients with confirmed diagnosis of chronic obstructive pulmonary disease (copd) * patients who have been on spiriva® handihaler® for ≥ 6 weeks at baseline visit * patients for whom a switch from spiriva® handihaler® to spiriva® respimat® was planned prior to study inclusion. if additional inhalative copd drugs (aicds) are used: aicd treatment must have been stable for at least 6 weeks before study inclusion * signed written informed consent form to participation exclusion criteria: * patients who have contraindications to spiriva® respimat® according to the current prescribing information label/ summary of product characteristics (smpc) * patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1 * patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks) * patients with confirmed diagnosis of only asthma * patients who had \> 1 moderate to severe exacerbation(s) within the last 6 weeks prior to study inclusion * patients who are pregnant or breastfeeding * patients participating in an ongoing interventional study